Tamper-Evident Pen Needle Outer Cover

ABSTRACT

A pen needle outer cover ( 10 ) has a molded plastic distal cover ( 20 ), and a molded plastic proximal cover ( 22 ) in place of the conventional paper-foil label. The proximal cover ( 22 ) may be snap-fit over the opening of the distal cover ( 20 ). A user-separable section ( 26 ) with a finger pull tab ( 32 ) is defined by a reduced-thickness membrane ( 24 ), which functions as a tear line to allow that section ( 26 ) to at least partially separate from the proximal cover ( 22 ). A living hinge ( 27 ) may be provided to keep the user-separable section ( 26 ) from completely separating from the proximal cover ( 22 ). The finger pull tab ( 32 ) may be configured to enable re-covering of a pen needle ( 30 ) that is still within the outer cover ( 10 ).

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/317,461, filed on Dec. 9, 2016, which claims priority from U.S.provisional patent application Ser. No. 62/009,475, filed on Jun. 9,2014, both of which are incorporated herein by reference in theirentirety.

FIELD OF THE INVENTION

This invention relates to packaging for individual pen needles that areadapted for attachment to a medication delivery device, such as amedication pen, and specifically to a closure for a pen needle distalouter cover.

BACKGROUND OF THE INVENTION

Pen needles are designed to be attached to a medication pen and areespecially useful for delivering self-administered injectablemedications, such as insulin. Medication pens and associated pen needlesare disclosed in U.S. Pat. No. 7,645,264, and in U.S. Patent ApplicationPublication Nos. 2009/0069755 and 2012/0022460, all of which areincorporated herein by reference in their entirety for their teachingsof pen needle design and construction.

In one well-known commercial pen needle device, a needle-bearing hub isprovided inside a funnel-shaped, outer plastic cover. The needle(cannula) is affixed in an axial bore of the hub with one end (the“injection end”) protruding from the distal or “patient side” of the huband covered by a removable inner cover, and the other end (the“non-injection end”) recessed in a cavity on the proximal or“non-patient” side of the hub, which is adapted for attachment to amedication pen. The hub and the injection end are received in the outercover, where the hub is secured in position by ribs, and a closure inthe form of a paper and foil “teardrop” label is heat-sealed on the edgeor flange of the open end of the cover. The user removes the label andholds the outer cover to install the hub, typically threading the hubonto the medication pen. Once the hub is installed on the pen, the outercover can be removed by pulling it distally off the hub. The inner coveris then removed from the injection end of the needle to allow aninjection to be made.

Current pen needle labels have a plastic layer on the underside and arefastened to the flange of a pen needle outer cover using heat to meltthe plastic layer to the plastic flange. The heating and its associateddwell time are critical, and must be maintained through hundreds ofthousands of sealing repetitions per day. In large-scale pen needlemanufacturing, this heat seal step may become a bottleneck orrate-limiting step. Therefore, one object of the invention is to providea closure for a pen needle outer cover that does not require aheat-sealing step to attach it to the outer cover, while retaining allthe sterility and ease-of-use functionality of current products.

Current pen needle labels may also be subject to delamination in someregions and under certain conditions where the labels are exposed tohigh levels of humidity, or if the packaging gets wet. Delamination canrender the pen needle unusable by leaving the plastic bottom layer ofthe label intact across the outer cover opening while the outer layersof the label delaminate when the patient tries to remove the label toaccess the needle. Therefore, another object of the invention is toavoid the drawbacks associated with delamination of a peel-type labelfor a pen needle.

A further problem addressed by the invention relates to providingevidence of tampering when a pen needle has been opened. Current penneedle labels can be reattached to the outer cover flange by reheatingthe plastic underlayer of the label and pressing it against the outercover flange, or by using adhesives. The pen needle label can be made tolook as though it is intact even though the sterility barrier has beencompromised. Thus, another object of the invention is to provide atamper-evident closure and labeling system.

Current pen needle labels are generally peeled completely off the outercover flange, which leaves the user with a loose piece to discard. Somepen needle users peel the label off only partially along its sealedarea, leaving a small portion of the label attached to the outer coverflange. This pattern of use makes it difficult to install the pen needleon a medication pen, as it requires the pen to be inserted into the penneedle cover at an angle to access the needle-bearing hub while avoidingthe hanging label, which could get caught between the threads of themedication pen and the needle hub. Thus, another object of the inventionis to provide a pen needle closure that allows the user to leave auser-separable portion of the closure attached to the outer cover whileleaving an unobstructed opening for installation of the pen-needle on amedication pen.

SUMMARY OF THE INVENTION

These and other objects of the invention are achieved, in one aspect,with a pen needle outer cover, comprising a plastic distal cover portionhaving a closed distal end and an opening at a proximal end with anattachment member adjacent the opening; and a plastic proximal coverportion engaging the attachment member and having a rupturable,thin-walled border portion defining a user-separable section of theproximal cover portion.

In embodiments, the rupturable, thin-walled border portion is preferablydisposed at a periphery of a top face of the plastic proximal coverportion. In this way, rupture of the thin-walled border portion isreadily discernable, so that a user can easily tell that the pen needlecover has been opened previously even though the opening of the distalcover is closed.

In embodiments, the user-separable section remains attached to theproximal cover portion by a living hinge after the pen needle is opened.In embodiments without a living hinge, the user-separable section can beremoved completely from the outer cover portion. The user-separablesection may have a finger pull tab at its outer end to facilitaterupture of the thin-walled body portion.

In embodiments, the distal cover portion includes a first latchingportion, while the proximal cover portion includes a second latchingportion configured to engage the first latching portion. The latchingportions can be incorporated, respectively, on a sidewall of the distalcover portion and on a finger pull tab of the user-separable section. Inembodiments, the latching portions can be released from and re-engagedwith each other to re-cover an opened pen needle.

In embodiments, the proximal cover portion is transparent, which enablesviewing of mating portions of the distal cover portion.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the disclosed invention are described in detail belowonly by way of example and with reference to the accompanying drawingfigures, which are not necessarily to scale.

FIG. 1 is a schematic, longitudinal cross-sectional view of a pen needleouter cover that shows certain basic features common to variousembodiments of the invention;

FIG. 2 is a perspective view of a pen needle outer cover according toanother embodiment of the invention;

FIG. 3 is another perspective view thereof; and

FIG. 4 is an elevational view thereof.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

As used herein, the “distal” direction is in the direction of theinjection site, and the “proximal direction” is the opposite direction.The “axial” direction is along the longitudinal axis of the cannula. Thecannula is generally arranged axially in the device. “Radially” is adirection perpendicular to the axial direction; thus, “radially inward”generally means closer to the needle.

Referring to FIG. 1, a pen needle outer cover 10 according to theinvention generally comprises a distal cover 20 and a proximal cover 22,both of which are injection molded parts made of plastic. In theillustrated embodiments, the distal cover 20 is a conventionalfunnel-shaped, substantially rigid pen needle outer cover that has anopen proximal end 14 and narrows in the distal direction to a closed end21. A commercial pen needle is installed in distal cover 20 through theopen proximal end 14. The pen needle has a needle 31 fixed in aneedle-bearing hub 30. The injection end of needle 31 is sheathed in aremovable inner cover 34. Threads 35 on the inside of hub 30 areconfigured to mate with the threads of a medication pen.

An attachment member in the form of an integral, outwardly directedflange 12 extends around substantially the entire open proximal end 14.In other embodiments, an attachment member on the distal cover 20 mayface inward at the edge of its proximal opening 14 and engage a matingmember on proximal cover 22. Other means for mounting proximal cover 22to the proximal end of distal cover 20 are also within the scope of theinvention.

As shown in FIG. 1, the proximal cover 22 of the invention is configuredwith a flexible, resilient, undercut skirt 23 to snap-fit over theflange 12 of distal cover 20. The embodiment of FIGS. 2-4 and otherspreferably have such a skirt or a similar snap-fit arrangement. Inembodiments, the attachment may be further secured by heat-shrinking anadditional membrane of cellophane or the like around the outer cover, oran adhesive may be applied to the underside of proximal cover 22. Otherouter cover shapes could also be employed within the scope of theinvention. Proximal cover 22 preferably is made of polyethylene,although polypropylene or other plastics known in the art and used inthis field may be used in other embodiments. The material may be opaquebut preferably is translucent, and more preferably is transparent sothat the interior of the outer cover can be viewed easily from theoutside. Proximal cover 22 is more rigid than the conventional paper andfoil “teardrop” labels that it replaces. Except for its flexible and/orrupturable portions described below, proximal cover 22 may be semirigidor substantially rigid.

While the two cover portions 20, 22 may be completely separable, it ispreferred that they remain at least partially attached to each other atall times. Thus, in the embodiment illustrated in FIGS. 2-4, only acentral user-separable section 26 of proximal cover 22 can be pulledback to provide access to the needle-bearing hub inside. In this case, arupturable, thin-walled border portion or membrane 24 functions as atear line and thus defines the user-separable section 26. The thicknessof this thin-walled membrane 24 may be selected by persons skilled inthe art to achieve the appropriate tear strength, depending on the covermaterial(s) used. In embodiments, a thickness of 0.004 to 0.012 mm, andpreferably 0.004 mm, for the thin-walled portion was found to provide anacceptable tear strength for the preferred injection molded polyethylenematerial.

If the thin-walled membrane 24 is continuous—i.e., if it extendsuninterrupted from one part of the proximal cover's outer edge toanother part of the outer edge, thus defining a closed shape—theuser-separable section 26 can be completely removed, leaving theremainder of proximal cover 22 intact on distal cover 20. Alternativelyand preferably, a living hinge 27 (see FIG. 2) on the proximal cover 22interrupts the thin-walled border portion 24. Living hinge 27 keeps theuser-separable section 26 partially attached to cover 22 when theuser-separable section is separated at the thin-walled border portion24. In the illustrated, preferred symmetrical arrangement, the livinghinge 27 divides the thin-walled border portion 24 into two equal-lengthsegments. The living hinge is a piece of plastic, co-molded with theproximal cover 22, that bends without breaking to allow theuser-separable section 26 to pivot open and provide unobstructed accessto the needle-bearing hub 30 through the opening at the proximal end 14of distal cover 20. Living hinge 27 is thinner than the majority ofproximal cover 22 but thicker than the thin-walled border portion 24.Details of the thickness and width of the living hinge may be left tothe discretion of persons skilled in the art, depending on the geometryof the proximal cover and the material used.

In embodiments, the user-separable section 26 is provided with a fingerpull tab 32 at its outer end, preferably opposite living hinge 27, tofacilitate its separation at the thin-walled border portion 24. Inembodiments that do not allow for complete removal of the user-separablesection 26, a latching arrangement 33 preferably is provided to permit auser to securely re-cover an opened pen needle with the user-separablesection 26 and thus protect against accidental needle sticks. Latchingarrangement 33 includes a first latching portion on proximal cover 22and a second latching portion on finger pull tab 32 configured to engagethe first latching portion. In the embodiment shown in FIGS. 3 and 4,the first latching portion is a laterally projecting nose 36 on theperiphery or sidewall of proximal cover 22, and the second latchingportion is a cooperating facing aperture 38 on pull tab 32 configured tocapture the nose 36. Alternatively, the latching mechanism may comprisean inwardly facing nose or rib on pull tab 32 that snaps under theperipheral edge of proximal cover 22; or it may comprise any othersuitable mating features on pull tab 32 and proximal cover 22 thatenable re-covering of the pen needle and hub by user-separable section26. Because rupture of the thin-walled border portion 24 is readilydiscernable, a user can easily tell that the pen needle cover has beenopened previously even though the opening of the distal cover is closed.

Molded indicia may be provided on the plastic proximal cover 22,viewable from the exterior of the cover. In preferred embodiments, theindicia are visible even after the user-separable section 26 isseparated along tear line 24. For example, the molded indicia may beprovided on the outer or inner surface of user-separable section 26 ifthat section remains connected by a living hinge or other means; or theindicia may be provided on a portion of the proximal cover 22 thatremains undisturbed. If the proximal cover 22 is transparent, indiciaapplied to its inner surface or to the adjacent flange 12 of the distalcover 20 will be readable through the plastic. The indicia may identifythe manufacturer of the part, the lot number, or provide other importantand potentially useful information.

The foregoing description of the preferred embodiments is not to bedeemed limiting of the invention, which is defined by the appendedclaims. Persons skilled in the art, relying on the foregoing disclosure,may practice variants of the embodiments described without departingfrom the scope of the invention claimed. Although described inconnection with the delivery of self-administered insulin, pen needlespackaged as described herein may be used to deliver other liquidmedications. Features described or claimed herein in connection with oneembodiment may be adapted for use with other embodiments withoutdeparting from the scope of the invention.

What is claimed is:
 1. A pen needle outer cover, comprising: a plasticdistal cover portion having a closed distal end, an opening at aproximal end and an attachment member adjacent the opening; and aplastic proximal cover portion engaging the attachment member, theproximal cover portion having a rupturable, thin-walled border portiondefining a user-separable section of the proximal cover portion, therupturable, thin-walled border portion being disposed at a periphery ofa top face of the plastic proximal cover portion.
 2. The pen needleouter cover according to claim 1, including a living hinge on theproximal cover portion connecting the user-separable section to theproximal cover portion and allowing the user-separable section to pivotwhen the rupturable, thin-walled border portion is ruptured.
 3. The penneedle outer cover according to claim 2, wherein the living hingedivides the rupturable, thin-walled border portion into two segments. 4.The pen needle outer cover according to claim 1, wherein theuser-separable section can be removed completely from the proximal coverportion.
 5. The pen needle outer cover according to claim 4, wherein therupturable, thin-walled border portion is continuous, thus defining aclosed shape.
 6. The pen needle outer cover according to claim 1,wherein the attachment member includes a flange adjacent the opening ofthe distal cover portion.
 7. The pen needle outer cover according toclaim 1, wherein the attachment member includes a flange runningsubstantially around the opening of the distal cover portion, and theproximal cover portion is snap-fit over the flange.
 8. The pen needleouter cover according to claim 1, wherein the distal cover portion andthe proximal cover portion are made of injection molded polyethylene andthe thin-walled border portion has a thickness in the range of 0.004 to0.012 mm.
 9. The pen needle outer cover according to claim 1, whereinthe user-separable section has a finger pull tab at an outer endthereof.
 10. The pen needle outer cover according to claim 1, whereinthe distal cover portion includes a first latching portion, and theproximal cover portion includes a second latching portion configured toengage the first latching portion.
 11. The pen needle outer coveraccording to claim 10, wherein the first latching portion can bereleased from and re-engaged with the second latching portion after theuser-separable section has been separated at the rupturable, thin-walledborder portion.
 12. The pen needle outer cover according to claim 9,wherein a sidewall of the distal cover portion includes a first latchingportion, and the finger pull tab includes a second latching portionconfigured to engage the first latching portion.
 13. The pen needleouter cover according to claim 12, wherein the first latching portioncan be released from and re-engaged with the second latching portionafter the rupturable, user-separable section has been separated at thethin-walled border portion.
 14. The pen needle outer cover according toclaim 13, wherein the first latching portion includes a lateralprojection and the second latching portion includes an apertureconfigured to capture the lateral projection.
 15. The pen needle outercover according to claim 1, wherein the proximal cover portion istransparent.
 16. A pen needle assembly, comprising: a hub and a cannulafixed axially to the hub; and the pen needle outer cover of claim
 1. 17.The pen needle assembly according to claim 16, including a living hingeon the proximal cover portion connecting the user-separable section tothe proximal cover portion and allowing the user-separable section topivot when the rupturable, thin-walled border portion is ruptured. 18.The pen needle assembly according to claim 17, wherein the living hingedivides the rupturable, thin-walled border portion into two segments.19. The pen needle assembly according to claim 16, wherein therupturable, thin-walled border portion defines a user-separable sectionthat can be removed completely from the proximal cover portion.
 20. Thepen needle assembly according to claim 19, wherein the rupturable,thin-walled border portion is continuous, thus defining a closed shape.